Further study details as provided by University of California, San Diego:

Biospecimen Retention: Samples With DNA

CSF, PBMC, plasma

Estimated Enrollment:

15

Study Start Date:

July 2008

Estimated Primary Completion Date:

July 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:

Child, Adult, Senior

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

Participants will be selected from participants already enrolled in Merck-sponsored Raltegravir Clinical Trials.

Criteria

Inclusion Criteria:

Enrollment in a raltegravir parent protocol at UCSD.

Willing to undergo lumbar puncture.

Able to give informed consent. If cognitively impaired, a test will be administered to ensure adequate comprehension of the consent document and procedure.

Exclusion Criteria:

Relative or absolute contraindication to lumbar puncture, such as current coagulopathy, thrombocytopenia (platelets<50,000/µL), hemophilia, or use of anticoagulant medication.

Psychiatric disease that would interfere with study participation, in the opinion of the investigator.

No major opportunistic infections within 30 days.

Moderate or severe cognitive impairment. The proposed study does not have a neuropsychological objective.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00718029